🇪🇺 L-DOPA/DDCI in European Union

EMA authorised L-DOPA/DDCI on 23 August 2011

Marketing authorisations

EMA — authorised 23 August 2011

  • Application: EMEA/H/C/002441
  • Marketing authorisation holder: Orion Corporation
  • Local brand name: Levodopa/Carbidopa/Entacapone Orion
  • Indication: Levodopa/Carbidopa/Entacapone Orion is indicated for the treatment of adult patients with Parkinson's disease and end-of-dose motor fluctuations not stabilised on levodopa / dopa-decarboxylase (DDC)-inhibitor treatment.
  • Status: approved

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EMA — authorised 19 November 2015

  • Application: EMEA/H/C/002611
  • Marketing authorisation holder: Amneal Pharma Europe Ltd
  • Local brand name: Numient
  • Indication: Symptomatic treatment of adult patients with Parkinson’s disease
  • Status: withdrawn

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EMA — authorised 27 April 2026

  • Application: EMEA/H/C/006429
  • Marketing authorisation holder: Tanabe Pharma GmbH
  • Local brand name: Onerji
  • Indication: Onerji is indicated for the treatment of motor fluctuations in patients with advanced Parkinson's disease which are not sufficiently controlled by oral anti-Parkinson medicinal products.
  • Status: approved

The European Medicines Agency (EMA) has approved Onerji (L-DOPA/DDCI) for the treatment of motor fluctuations in patients with advanced Parkinson's disease. This condition is not adequately controlled by oral anti-Parkinson medicinal products. The approval was granted to Tanabe Pharma GmbH, the marketing authorisation holder, on 27 April 2026.

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L-DOPA/DDCI in other countries

Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.

Other Neurology approved in European Union

Frequently asked questions

Is L-DOPA/DDCI approved in European Union?

Yes. EMA authorised it on 23 August 2011; EMA authorised it on 19 November 2015; EMA authorised it on 27 April 2026.

Who is the marketing authorisation holder for L-DOPA/DDCI in European Union?

Orion Corporation holds the EU marketing authorisation.